基于比值失衡法对利拉鲁肽上市后安全信号的检测与评价  

Detection and Evaluation of Post Marketing Safety Signals of Liraglutide Based on Ratio Imbalance Method

作　　者：季欢欢[1] 霍本念 张妮[1] 宋林[1] 贾运涛[1] JI Huanhuan;HUO Bennian;ZHANG Ni;SONG Lin;JIA Yuntao(Department of Pharmacy, Ministry of Education Key Laboratory of Child Development and Disorders, National Clinical Research Center for Child Health and Disorders,China International Science and Technology Cooperation Base of Child Development and Critical Disorders,Chongqing Key Laboratory of Pediatrics, Children's Hospital of Chongqing Medical University, Chongqing 400014,China)

机构地区：[1]重庆医科大学附属儿童医院药学部,儿童发育疾病研究教育部重点实验室,国家儿童健康与疾病临床医学研究中心,儿童发育重大疾病国家国际科技合作基地,儿科学重庆市重点实验室,重庆400014

出　　处：《医药导报》2022年第1期48-53,共6页Herald of Medicine

基　　金：重庆医科大学2021年校级研究生教育教学改革研究项目(xyjg210219);重庆市教育委员会暨重庆医科大学校级项目(ZHYX2019022);重庆市临床药学重点专科建设项目[渝卫办发(2020)68号]。

摘　　要：目的通过对利拉鲁肽上市后大样本数据安全信号的挖掘分析,为临床合理安全用药提供参考。方法采用报告比值比(ROR)法和比例报告比值法(PRR)对美国食品药品管理局(FDA)不良事件报告系统(FAERS)数据库2010年1月25日—2021年第1季度收录的利拉鲁肽相关报告进行数据挖掘。从国际医学用语词典(MedDRA)的首选语(PT)、高位语(HLT)、标准MedDRA分析查询(SMQ)3个维度分析药品不良事件(ADE)安全信号。结果以利拉鲁肽为首要怀疑药品的不良事件报告24957份,在HLT层级得到53个信号,SMQ层级得到12个信号,PT/HLT/SMQ层级上报频数前30位事件分别检出21,15,9个信号,且两种算法信号完全重合。信号结果主要表现为胃肠道不良反应、急性及慢性胰腺炎、急性胆囊疾病及低血糖等事件。将信号进行规整比对,其中涉及的10个事件说明书未收录。结论上市后不良反应信号监测有助于了解利拉鲁肽安全性事件特征,可为进一步的药物警戒工作奠定基础。Objective To excavate and analyze the safety signals of liraglutide,so as to provide a reference for clinical safety and rational use.Methods The ratio of reporting odd ratio(ROR)method and the proportional reporting ratio(PRR)method were used to perform data on the liraglutide-related reports included in American Food and Drug Administration Adverse Event Reporting System(FAERS)from January 25,2010 to the first quarter of 2021.The safety signals were analyzed from the three dimensions:preferred language(PT),high-level language(HLT),and standardized MedDRA(Medical Dictionary for Regulatory Activities)query(SMQ)of MedDRA.Results There were 24957 ADE reports with liraglutide as the primary suspected drug,of 53 signals were obtained at the HLT level,12 signals at the SMQ level,and 21,15,and 9 signals were detected at the top 30 events reported by the PT/HLT/SMQ level,respectively.The signals of these algorithms were completely coincident.Signal results were mainly manifested as gastrointestinal adverse reactions,acute and chronic pancreatitis,acute gallbladder disease,and hypoglycemia.The signals were organized and compared,and the 10 events involved not included in drug label.Conclusion Post-marketing adverse reaction signal monitoring is helpful to understand the characteristics of liraglutide safety events,which can lay the foundation for further pharmacovigilance work.

关 键 词：利拉鲁肽 药品不良事件 合理用药 

分 类 号：R977.15[医药卫生—药品] R969.3[医药卫生—药学]